Australia and the Asia Pacific are fast becoming the destination of choice for the over US$140 billion international biotech industry [1], with considerable research incentives, supportive regulatory environments and affordable trial costs available.
The increase in industry participation in the Asia Pacific region was highlighted in a private event during Biotech Showcase 2018, where Asia Pacific CRO Novotech and specialist compliance group CoSec Consulting briefed industry leaders on the clinical trial benefits available.
The Asia Pacific region has a wealth of clinical trial benefits to offer biotech companies, regardless of their stage of research explained Novotech CRO Chief Executive Officer Dr John Moller.
“Like any business, biotech companies need to maximise cost efficiencies and regulatory speed, and access leading clinical trial infrastructure and decision makers in the regions in which they operate,” Dr Moller said, “Australia is able to provide a fast and supportive clinical trial environment, especially for early stage research. A cost comparison study has found that clinical research costs in Australia are up to 60% cheaper than the US for companies able to fully utilise R&D incentives.”
CoSec Consulting Managing Partner, Mr Blair Lucas, said Australia’s supportive clinical trial environment is a smart financial decision for international biotech companies undertaking early stage research.
“Australia’s tax and company compliance environment is transparent and efficient, which has enabled us to provide a simple, fixed-cost model for foreign-domiciled biotech companies seeking to establish operations in Australia,” Mr Lucas said. “These tax incentives include a 43.5% refundable cash benefit for eligible research and development activities in Australia.”
Dr Moller said that many governments across Asia are prioritising the benefits of clinical trials to their economies and health sectors; and are working hard to reduce many of the previous barriers to entry by reducing regulatory hurdles, decreasing clinical trial approval and start up timelines, and increasing levels of government support.
“Major advancements during 2017 included the significant restructure by China’s FDA to many aspects of its regulatory framework, with the changes outlined in Circular 53 now being implemented,” said Dr Moller, “Malaysia has prioritized its clinical trial industry as part of its Economic Transformation Program and launched its first Phase I Clinical Trial Guidelines; while South Korea changed its healthcare policy to now cover the standard of care of patients participating in clinical trials. India also simplified its regulatory approval process in a bid to revitalise its clinical trial industry.Novotech is committed in providing our clients with access to the untapped benefits available in the Asia Pacific region.”
As the leading Asia Pacific CRO, Novotech has 13 offices in 11 countries throughout in the Asia Pacific and actively works with each country’s regulatory authorities and key clinical trial centres to improve approval processes and timelines. Novotech has recently launched a central labs service in Australia, launched a site monitoring (SMO) business to support clinical trial activity in South Korea and Taiwan; and signed two MOUs with leading clinical trial networks in South Korea.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
For all enquiries, please contact Novotech CRO Director Barry Murphy on barry.murphy@novotech-cro.com or +1 415 767-3663
For RFPs, please fill out the form available at www.novotech-cro.com/contact-us
About CoSec Consulting – www.cosec.com.au
CoSec Consulting provides specialist compliance, governance and financial solutions for offshore companies undertaking research and development activities in Australia. CoSec has a particularly strong track-record in hosting life sciences companies that are establishing subsidiaries in Australia for the purpose of conducting clinical trials.
CoSec’s team of accountants, tax agents and legal professionals offer a full range of highly integrated financial, administrative and advisory services to help companies fulfil their regulatory obligations. In addition to its core compliance and accountancy support, CoSec provides overseas clients with a full suite of registered office and CFO services, and its specialist R&D Advisor also helps clients find out how to take advantage of the country’s world-class program of tax incentives for R&D expenditure. CoSec is headquartered in Melbourne, with senior consultants based in Sydney, Brisbane, Adelaide and San Francisco.
For all enquiries in North America, please contact CoSec Vice President - North America Stewart Walker on stewart.walker@cosec.com.au or +1 415 310 6252
[1] Statista.com: ‘Global biotechnology industry revenue by selected geographical location from 2013 to 2016 (in billion U.S. dollars)’